Package Leaflet: Information for the user

FOSTAIR*

200/6 micrograms per actuation pressurised inhalation solution

beclometasone dipropionate/ formoterol fumarate dihydrate

For use in adults.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects talk with your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Fostair is and what it is used for

2.    What you need to know before you use Fostair

3.    How to use Fostair

4.    Possible side effects

5.    How to store Fostair

6.    Contents of the pack and other information

1.    What Fostair is and what it is used for

Fostair is a pressurised inhalation solution containing two active substances which are inhaled through your mouth and delivered directly into your lungs.

The two active substances are:

Beclometasone dipropionate, which belongs to a group of medicines called corticosteroids that have an anti-inflammatory action reducing the swelling and irritation in your lungs.

Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting bronchodilators that relax the muscles in your airways and helps you to breathe more easily.

These two active substances make breathing easier. They also help to prevent asthma symptoms such as shortness of breath, wheezing and coughing.

Fostair is used to treat asthma in adults.

If you are prescribed Fostair it is likely that either:

•    your asthma is not adequately controlled by using inhaled corticosteroids and “as needed” short-acting bronchodilators or

•    your asthma responds well to both corticosteroids and long-acting bronchodilators

2.    What you need to know before you use Fostair Do not use Fostair:

•    if you are allergic to beclometasone dipropionate or formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Fostair if you have any of the following:

•    heart problems, such as angina (heart pain, pain in the chest), heart failure, narrowing of the arteries, valvular heart disease or any other known abnormalities of your heart

•    high blood pressure or if you know that you have an aneurysm (an abnormal bulging of the blood vessel wall)

•    disorders of your heart rhythm such as increased or irregular heart rate, a fast pulse rate or palpitations, or if you have been told that your heart trace is abnormal

•    an overactive thyroid gland

•    low blood levels of potassium

•    any disease of your liver or kidneys

diabetes (if you inhale high doses of formoterol your blood glucose may increase. When you start using this medicine and from time to time during treatment you may need to have some additional blood tests to check your blood sugar)

•    tumour of the adrenal gland (known as a phaeochromocytoma)

•    are due to have an anaesthetic. Depending on the type of anaesthetic, it may be necessary to stop taking Fostair for at least 12 hours before the anaesthesia

•    you are being, or have ever been, treated for tuberculosis (TB) or if you have a known viral or fungal infection of your chest

•    you must avoid alcohol for any reason

If any of the above applies to you, always inform your doctor before you use Fostair

If you have or had any medical problems or allergies or if you are not sure whether you can use Fostair talk

to your doctor, asthma nurse or pharmacist before using this medicine.

Your doctor may wish to measure the potassium levels in your blood from time to time especially if your asthma is severe. Like many bronchodilators Fostair can cause a sharp fall in your serum potassium level (hypokalaemia). This is because a lack of oxygen in the blood combined with some other treatments you may be taking together with Fostair can make the fall in potassium level worse.

If you take higher doses of inhaled corticosteroids over long periods, you may have more of a need for corticosteroids in situations of stress. Stressful situations might include being taken to hospital after an accident, having a serious injury or before an operation. In this case, the doctor treating you will decide whether you may need to increase your dose of corticosteroids and may prescribe some steroid tablets or a steroid injection.

Should you need to go to the hospital, remember to take all of your medicines and inhalers with you, including Fostair and any medicines or tablets bought without a prescription, in their original packaging, if possible.

Children and adolescents

Fostair should not be used in children and adolescent less than 18 years old, until further data become available.

Other medicines and Fostair:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Do not use beta blockers with this medicine. If you need to use beta blockers (such as medicines used to treat high blood pressure or glaucoma, including eye-drops), the effect of formoterol may be reduced or it may not work at all.

Using Fostair together with:

•    medicines for treating abnormal heart rhythms (quinidine, disopyramide, procainamide), medicines used to treat allergic reactions (antihistamines), medicines for treating symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines - can cause some changes in the electrocardiogram (ECG, heart trace). They may also increase the risk of disturbances of heart rhythm (ventricular arrhythmias)

•    beta adrenergic medicines (medicines which work in the same way as formoterol) - may increase the effects of formoterol

•    medicines for treating Parkinson’s Disease (L-dopa), to treat an underactive thyroid gland (L-thyroxine), medicines containing oxytocin (which causes uterine contraction) and alcohol - can lower your heart’s tolerance to beta-2 agonists, such as formoterol

•    monoamine oxidase inhibitors (MAOIs), including medicines with similar properties like furazolidone and procarbazine, used to treat mental disorders - can cause a rise in blood pressure

•    medicines for treating heart disease (digoxin) - can cause a fall in your blood potassium level. This may increase the likelihood of abnormal heart rhythms

•    other medicines used to treat asthma (theophylline, aminophylline or steroids) and diuretics (water tablets) - may cause a fall in your potassium level

•    some anaesthetics - can increase the risk of abnormal heart rhythms

Pregnancy, breast-feeding and fertility

There are no clinical data on the use of Fostair during pregnancy.

Fostair should not be used if you are pregnant, think that you might be pregnant or are planning to become pregnant, or if you are breast-feeding, unless you are advised to do so by your doctor.

Driving and using machines

Fostair is unlikely to affect your ability to drive and use machines.

Fostair contains alcohol

Fostair contains a small amount of alcohol (ethanol). Every actuation (puff) from your inhaler contains 9 mg of ethanol. 3. How to use Fostair Fostair is for inhalation use.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Asthma

Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Fostair. Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.

Dosage:

Adults and the elderly:

The recommended dose is two actuations twice daily.

The maximum daily dose is 4 actuations.

Remember: You should always have your quick-acting “reliever” inhaler with you at all times to treat worsening symptoms of asthma or a sudden asthma attack.

At-risk patients:

There is no need for dose adjustment if you are older. No information is available regarding the use of Fostair in people with liver or kidney problems.

Use in children and adolescents less than 18 years of age:

Children and adolescents aged less than 18 years must NOT take this medicine.

Fostair is effective for the treatment of asthma in a dose of beclometasone dipropionate which may be lower than that of some other inhalers containing this substance. If you have been using a different inhaler containing beclometasone dipropionate previously, your doctor will advise you on the exact dose of Fostair you should take for your asthma.

Do not increase the dose

If you feel that the medicine is not very effective, always talk to your doctor before increasing the dose.

If your asthma gets worse:

If your symptoms get worse or are difficult to control (e.g. if you are using a separate “reliever” inhaler more frequently) or if your “reliever” inhaler does not improve your symptoms, see your doctor immediately. Your asthma may be getting worse and your doctor may need to change your dose of Fostair or prescribe alternative treatment.

Method of administration:

Fostair is for inhalation use

If the inhaler has been exposed to severe cold, take the canister out of the mouthpiece and warm it with your hands for a few minutes before using. Never warm it by artificial means.

Before using the inhaler for the first time or if you have not used the inhaler for 14 days or more, release one actuation into the air to make sure the inhaler is working properly. Whenever possible, stand or sit in an upright position when inhaling.

1.    Remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.

2.    Breathe out as slowly and deeply as possible.

3.    Hold the canister vertically with its body upwards and put your lips around the mouthpiece. Do not bite the mouthpiece.

4.    Breathe in slowly and deeply through your mouth and, just after starting to breathe in press down on the top of the inhaler to release one actuation.

5.    Hold your breath for as long as possible and, finally, remove the inhaler from your mouth and breathe out slowly. Do not breathe into the inhaler.

6.    After use, close with the protective cap.

If you need to take another actuation, keep the inhaler in the vertical position for about half a minute, then repeat steps 2 to 5. Important: Do not perform steps 2 to 5 too quickly.

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If you see ‘mist’ coming from the top of the inhaler or the sides of your mouth you should start again from step 2.

If you have weak hands, it may be easier to hold the inhaler with both hands: hold the upper part of the inhaler with both index fingers and its lower part with both thumbs.

To lower the risk of a fungal infection in the mouth and throat, rinse your mouth, gargle with water or brush your teeth each time you use your inhaler.

If you think the effect of Fostair is too much or not enough, tell your doctor or pharmacist.

If you find it difficult to operate the inhaler while starting to breathe in you may use the AeroChamber Plus spacer device. Ask your doctor, pharmacist or a nurse about this device.

It is important that you read the package leaflet which is supplied with your AeroChamber Plus spacer device and that you follow the instructions on how to use and how to clean it, carefully.

Cleaning

It is important that you clean your inhaler regularly (once weekly) to prevent blockage:

•    Pull the metal canister out of the plastic case and remove the cap from the mouthpiece. Rinse the mouthpiece and cap with warm water. Leave the inhaler to dry (overnight).

•    Put the canister back into the plastic case and close the mouthpiece with protective cap.

If you use more Fostair than you should:

•    taking more formoterol than you should can have the following effects: feeling sick, being sick, heart racing, palpitations, disturbances of heart rhythm, certain changes in the electrocardiogram (heart trace), headache, trembling, feeling sleepy, too much acid in the blood, low blood potassium levels, high levels of glucose in the blood. Your doctor may wish to carry out some blood tests to check your blood potassium and blood glucose levels

•    taking too much beclometasone dipropionate can lead to short-term problems with your adrenal glands. This will get better within a few days however your doctor may need to check your serum cortisol levels

Tell your doctor if you have any of these symptoms.

If you forget to use Fostair:

Take it as soon as you remember. If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop using Fostair:

Even if you are feeling better, do not stop taking Fostair or lower the dose. If you want to do this, talk to your doctor. It is very important for you to use Fostair regularly even though you may have no symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As with other inhaler treatments there is a risk of worsening shortness of breath and wheezing immediately after using Fostair and this is known as paradoxical bronchospasm. If this occurs you should STOP using Fostair immediately and use your quick-acting “reliever” inhaler straightaway to treat the symptoms of shortness of breath and wheezing. You should contact your doctor immediately.

Tell your doctor immediately if you experience any hypersensitivity reactions like skin allergies, skin itching, skin rash, reddening of the skin, swelling of the skin or mucous membranes especially of the eyes, face, lips and throat.

Other possible side effects are listed below according to their frequency.

Common (may affect up to 1 in 10 people):

•    fungal infections (of the mouth and throat)

•    headache

•    hoarseness

•    sore throat

Uncommon (may affect up to 1 in 100 people):

•    palpitations, unusually fast heart beat and heart rhythm disorders

•    some changes in the electrocardiogram (ECG)

•    increase in blood pressure

•    flu like symptoms

•    sinus inflammation

•    rhinitis

•    inflammation of the ear

•    throat irritation

•    cough and productive cough

•    asthma attack

•    fungal infections of the vagina

•    nausea

•    abnormal or impaired sense of taste

•    burning of the lips

•    dry mouth

•    swallowing difficulties

•    indigestion

•    upset stomach

•    diarrhoea

•    pain in muscle and muscle cramps

•    reddening of the face and throat

•    increased blood flow to some tissues in the body

•    excessive sweating

•    trembling

•    restlessness

•    dizziness

•    nettle rash or hives

•    alterations of some constituents of the blood:

° fall in the number of white blood cells

° increase in the number of blood platelets ° fall in the level of potassium in the blood ° increase in blood sugar level

° increase in the blood level of insulin, free fatty acid and ketones

The following side effects have also been reported as “uncommon” in patients with chronic obstructive pulmonary disease:

•    pneumonia; tell your doctor if you notice any of the following symptoms: increase in sputum production, change in sputum colour, fever, increasing cough, increased breathing problems

•    reduction of the amount of cortisol in the blood; this is caused by the effect of corticosteroids on your adrenal gland

•    irregular heart beat

Rare (may affect up to 1 in 1,000 people):

•    chest tightness

•    missed heartbeat (caused by premature contraction of the heart’s ventricles)

•    decrease in blood pressure

•    kidney inflammation

•    swelling of skin and mucous membrane persisting for several days

Very rare (may affect up to 1 in 10,000 people):

•    shortness of breath

•    worsening of asthma

•    a fall in the number of blood platelets

•    swelling of the hands and feet

Using high-dose inhaled corticosteroids over a long time can cause in very rare cases systemic effects. These include:

•    problems with how your adrenal glands work (adreno-suppression)

•    decrease in bone mineral density (thinning of the bones)

•    growth retardation in children and adolescents

•    increased pressure in your eyes (glaucoma)

•    cataracts

Not known (frequency cannot be estimated from the available data):

•    sleeping problems

•    depression or anxiety

•    restlessness

•    nervousness

•    feeling over-excited or irritable.

These events are more likely to occur in children but the frequency is not known.

Reporting side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Fostair

Keep this medicine out of the sight and reach of children.

Do not use Fostair beyond 5 months from the date you get the inhaler from your pharmacist and never use after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

Do not store the inhaler above 25 °C.

Warning: The canister contains a pressurised liquid. Do not expose the canister to temperatures higher than 50 °C. Do not pierce the canister.

Medicines should not be disposed of via waste water or household waste. Return all used, partially used and unused inhalers to your pharmacist to be disposed of. These measures will help to protect the environment.

6.    Contents of the pack and other information What Fostair contains:

The active substances are: beclometasone dipropionate, formoterol fumarate dihydrate.

Each metered dose from the inhaler contains 200 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose from the mouthpiece of 177.7 micrograms of beclometasone dipropionate and 5.1 micrograms of formoterol fumarate dihydrate.

The other ingredients are: norflurane (HFA 134-a), ethanol anhydrous, hydrochloric acid.

What Fostair looks like and contents of the pack:

Fostair is a pressurised inhalation solution contained in an aluminium canister with a metering valve, fitted in a plastic actuator with a plastic protective cap.

Each pack contains:

1    pressurised container (which provides 120 actuations)

2    pressurised containers (which provide 120 actuations each)

1 pressurised container (which provides 180 actuations)

Not all pack sizes may be marketed.

Marketing authorisation holder:

Chiesi Limited,

333 Styal Road,

Manchester, M22 5LG, UK.

Manufacturer responsible for batch release:

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A 43122 Parma - Italy

Alternative manufacturers responsible for batch release:

Chiesi Pharmaceuticals GmbH Gonzagagasse 16/16 1010 Wien - Austria

Chiesi S.A.

11, avenue Dubonnet 92400 Courbevoie - France

This leaflet was last revised in: January 2016

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G Chiesi

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